Role of Prophylactic Metoclopramide With Tramadol in Trauma Patients

NCT03383315 | Completed Phase 2

• 1 other identifier: NMRR-16-1688-32638
• Study Type: interventional
• Target: 191
• Locations: 1 country
• Sites: 1

Brief Summary

Tramadol is widely used as analgesic in trauma patients. However, it causes side effects, most notably nausea and vomiting. This study aim to determine the role of prophylactic metoclopramide in preventing tramadol induced nausea and vomiting.

Conditions

Trauma; Opioid Analgesic Adverse Reaction

Outcome Measures

Primary Outcomes (1)

• Nausea severity scale

  Change in rating of nausea severity on Visual Analogue Scale 60 minutes after administration of the study drugs. VAS is a standard 100mm line marked "no nausea" at the left end and "worst nausea imaginable" at the right end. Minimum clinically significant difference is defined for this study as 20 mm increment.

  One hour

Secondary Outcomes (1)

• Vomiting

  One hour

Study Arms (2)

Group 1

EXPERIMENTAL

Intravenous tramadol 50mg + intravenous metoclopramide 10mg

Drug: Tramadol; Drug: Metoclopramide

Group 2

ACTIVE COMPARATOR

Intravenous tramadol 50mg + placebo (normal saline)

Drug: Tramadol; Drug: Placebo

Interventions

Tramadol DRUG

One dose of intravenous tramadol 50mg

Group 1; Group 2

Metoclopramide DRUG

One dose of intravenous metoclopramide 10mg

Group 1

Placebo DRUG

Sodium chloride 0.9%

Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18 years or older on day of presentation to ETD SGH
• Sustained from traumatic injuries of extremities (Fracture of hand \& wrist, radius, ulna, humerus, femur, tibia, fibula and/or foot \& ankle; laceration wounds of extremities; soft tissue injury)
• Patient who is able to give consent

You may not qualify if:

• Known allergy to metoclopramide
• Concurrently taking medication with anti-emetic effect, including antihistamines, phenothiazines and dopamine antagonists.
• A history of vomiting since time of injury
• Patients who had already received tramadol or metoclopramide in the previous 8 hours prior to arrival at ETD
• Below age of 18 on day of presentation, or patients who could not consent to the study
• Any alteration in level of consciousness
• Hemodynamic instability or primary diagnosis requiring time critical intervention
• Pregnancy or lactation
• History or known case of vertiginous disorder
• Currently undergoing chemotherapy or radiotherapy

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

Sarawak General Hospital

Kuching, Sarawak, 93586, Malaysia

Location

MeSH Terms

Conditions

Wounds and Injuries

Interventions

Tramadol; Metoclopramide

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids; Benzamides; Amides; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Chlorobenzoates; Hydroxybenzoate Ethers; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenyl Ethers; Phenols

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The study drugs were prepared under sterile conditions by a pharmacist independent to the study and kept in packs.The patients recruited were randomized to receive one of the study packs. The study pack were numbered by the pharmacist, who used a computer-generated random number sequence to assign treatment allocations. The allocation list was kept by the pharmacist. Treatment allocations were revealed only after study completion, when all outcome measurements had been performed and recorded by the investigator in the study database.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: Patients are randomized into two groups. One group receives tramadol and metoclopramide, while another group receives tramadol and placebo (normal saline).

Study Record Dates

• First Submitted: December 18, 2017
• First Posted: December 26, 2017
• Study Start: July 1, 2017
• Primary Completion: September 30, 2017
• Study Completion: September 30, 2017
• Last Updated: December 26, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)